Prostate Cancer
Conditions
Keywords
prostate, cancer, vitamin D3, early stage, active surveillance
Brief summary
This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
4,000 I.U. softgel daily orally for 48 weeks
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* lowgrade prostate cancer * serum PSA less than/equal to 10 ng/ml * Gleason score less than/equal to 6 * referred from their treating physician with treatment plan of active surveillance for one year * serum creatinine less than/equal to 2.0 mg/dL * serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL * serum calcium greater than 8.5 and less than 10.5 mg/dL
Exclusion criteria
* concurrent malignancy, except non-melanoma skin cancer * history of sarcoidosis * history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation * history of hypercalcemia * treatment with lithium medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer. | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily. | 48 weeks |
Countries
United States
Outcome results
None listed